Lilli Zakarija is Co-Founder and President of EdgeOne Medical Inc and has over 20 years of experience in the medical device industry. Her expertise includes development and global launch of various single-use, disposable medical devices and combination products, strategic/technical development of device platforms and IP management. Throughout her career she has held management roles in engineering and project management, and prior to founding EdgeOne Medical Lilli established and led the global engineering function supporting all device and combination product related needs for the BioScience division of Baxter Healthcare (now Baxalta a Shire company).
Lilli has a Bachelor of Science in Biomedical Engineering and a Master in Engineering Management from Northwestern University, and an Executive MBA from Kellogg School of Management. In addition, Lilli serves on the Board of Directors for Women in Bio - Chicago Chapter, Board of Advisors for Biomedical Engineering Dept at Northwestern University, is a Chicago Innovation Mentor (CIM), and is a speaker on device development and combination products.
Joe Braido is a Co-Founder and was responsible for developing EdgeOne Medical's Quality and Regulatory Affairs function. He has over 20 years of experience at Hill-Rom, Abbott Laboratories, Baxter Healthcare, and Eli Lilly. His expertise includes development of regulatory strategies, preparation of FDA submissions (Class II and Class III), CE Marking Technical Files, quality system development, implementation, and remediation with an emphasis in Risk management and Development. Throughout his career he has held management roles in quality and regulatory affairs and most recently was Corporate Director of Quality Risk Management at Baxter.
Mr. Braido has a Bachelor of Science in Biology from Benedictine University. He is a member of the American Society for Quality (ASQ). His professional certifications included RAPS Regulatory Affairs Certification (RAC - US), as well as an ASQ Certified Manager of Operational Excellence (CMQ/OE). He is also speaker for topics in his area of expertise, and is currently an Adjunct Professor at the Northwestern University School of Law. Joe is co-founder of a non-profit organization called Echo Foundation.
Scott Ariagno is Vice President of Engineering and Development Services at EdgeOne Medical and has over 20 years in medical device and combination product design, development and manufacturing. His expertise includes development and global launch of of various single-use, disposable medical devices, infusion systems and combination products, strategic/technical development of device platforms and IP development. Throughout his career he has held management roles in engineering including heading device development and external manufacturing at Shire (now Takeda). Scott is a named inventor on over 20 patents and applications.
Scott has Bachelor of Science in Mechanical Engineering from Bradley University and a Master in Engineering Management from Northwestern University.
Jerzy Wojcik is Vice President of Quality and Regulatory Affairs Services at EdgeOne Medical Inc., and has over 25 years of industry experience in quality and regulatory affairs at Baxter Healthcare, Avery Dennison Medical (Vancive Medical), Deloitte, Abbott Laboratories and Baxter (Takeda) BioLife Plasma Services. His expertise includes identification and execution of regulatory activities across all stages of product development and lifecycle management necessary to support Class I, II and III (in both US and EU) medical device, device-biological and device-drug combination products, including wearable sensors and mobile medical applications. Jerzy also has expertise in US distribution and dispensing regulation compliance and US regulatory surveillance for drug, biologics and devices. In addition to medical product regulatory responsibilities, Jerzy also helped develop and implement quality systems and various process quality compliance initiatives.
Mr. Wojcik has a Bachelor of Science in Biology, Medical Technology and Cytotechnology from Augustana College, IL, and was an Adjunct Professor in the School of Law at Northwestern University, IL. He is a member of Regulatory Affairs Professional Society (RAPS) and volunteers with Chicago Innovation Mentors (CIM). Jerzy speaks Polish and Spanish.